A Phase I, Open-Label, Multi-Center Study of the Safety, Pharmacokinetics (PK), and Anti-Tumor Activity of LYT-200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/Refractory, High-Risk Myelodysplastic Syndrome (MDS)
Details
We are enrolling cancer of the blood and bone marrow patients. In this study, we are looking at a new investigational drug called LYT-200 that is intended to inhibit (hinder) galectin-9. Galectin-9 is a protein which suppresses immune functionand disables immune-mediated attack on the cancer cells through multiple pathways. At present, there are no approved therapies targeting galectin-9 for any disease. Early studies conducted in
animals suggest LYT-200 might be a good treatment for patients with blood and bone marrow
cancer.
This study is among the first research studies of LYT-200 in people and its main purpose is to
test its safety and tolerability in patients suffering from two types of blood and bone marrow
cancer: acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). In this study we
shall also examine how the drug is changed by and removed from the body and will look for
signs that the drug may be effective against AML or MDS. LYT-200 will be tested at several
different doses.
Eligibility
You can join if...
You have had at least one line of therapy for AML or MDS and your cancer relapsed or
was refractory (resistant) to treatment and there are no standard treatment options
available that are known to be effective to treat your cancer or you have refused to
receive treatment with standard of care treatments.
You are up and about and are able to visit the study center frequently.
You have satisfactory blood test results and medical examination.
You are able to conceive a child, you are not pregnant and you agree to use two forms
of birth control (one of which must be a barrier method) starting at screening and for
90 days after receiving the final study drug administration.
You and your partner who could conceive a child agree to use two forms of birth
control (one of which must be a barrier method) starting at screening.
You have agreed not to donate your reproductive material (ova) or breastfeed for the
period of the study and for 90 days after receiving the final study drug administration.
You have not taken any anticancer medications in at least the last 2 weeks or in the
amount of time needed for the previous anticancer medication to clear from your body
(otherwise known as half-life of the drug), which can be shorter than 2 weeks, and your
doctor will know.
You have not had major surgery or radiation therapy within 4 weeks prior to the first
study dose.
You have not received any live vaccine within 30 days prior to the first study dose.